Primary Device ID | 00854732006003 |
NIH Device Record Key | 15c1b213-8631-47ae-80e1-a049328e0f04 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | UreTron Generator |
Version Model Number | URT-G-US |
Company DUNS | 009836084 |
Company Name | MED-SONICS CORPORATION |
Device Count | 1 |
DM Exempt | false |
Pre-market Exempt | false |
MRI Safety Status | Labeling does not contain MRI Safety Information |
Human Cell/Tissue Product | false |
Device Kit | false |
Device Combination Product | false |
Single Use | false |
Lot Batch | false |
Serial Number | true |
Manufacturing Date | false |
Expiration Date | false |
Donation Id Number | false |
Contains Natural Rubber Latex | false |
Labeled No Natural Rubber Latex | false |
RX Perscription | true |
OTC Over-The-Counter | false |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00854732006003 [Primary] |
FFK | Lithotriptor, Electro-Hydraulic |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 3 |
Public Version Date | 2018-07-06 |
Device Publish Date | 2016-09-01 |
00854732006003 - UreTron Generator | 2018-07-06UreTron Lithotripter Generator |
00854732006003 - UreTron Generator | 2018-07-06 UreTron Lithotripter Generator |
00854732006010 - UreTron Rigid Hand Piece | 2018-07-06 UreTron Rigid Hand Piece |
00854732006027 - UreTron Flex Hand Piece | 2018-07-06 UreTron Flex Hand piece for Flex and Semi Flex Probes |
10854732006031 - UreTron Rigid Sterile Probe 3.1 x 370mm | 2018-07-06 UreTron Rigid Sterile Probe 3.1 x 370mm |
00854732006041 - UreTron Rigid Sterile Probe 3.5 x 370 mm | 2018-07-06 UreTron Rigid Sterile Probe 3.5 x 370 mm |
00854732006058 - UreTron Rigid Sterile Probe 3.5 x 430mm | 2018-07-06 UreTron Rigid Sterile Probe 3.5 x 430mm |
00854732006065 - UreTron Rigid Sterile Probe 3.1 x 430 mm | 2018-07-06 UreTron Rigid Sterile Probe 3.1 x 430 mm |
00854732006072 - UreTron Semi Rigid Sterile Probe 1.9 x 370 mm | 2018-07-06 UreTron Semi Rigid Sterile Probe 1.9 x 370 mm |